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EMA Recommends Extension of Indications for Pomalidomide

New indication concerns treatment of adult patients with multiple myeloma in combination with bortezomib and dexamethasone after at least one prior regimen including lenalidomide
29 Mar 2019
Haematologic malignancies;  Anticancer agents & Biologic therapy

On 28 March 2019, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product pomalidomide (Imnovid).

The marketing authorisation holder for this medicinal product is Celgene Europe BV.

The CHMP adopted an extension to the existing indication as follows:

Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

Already authorised indication is:

Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

Last update: 29 Mar 2019

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